Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-05 @ 1:30 PM
Study NCT ID:
NCT00258492
Status:
UNKNOWN
Last Update Posted:
2007-01-26
First Post:
2005-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restless Legs Syndrome Exercise Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2007-01-25', 'studyFirstSubmitDate': '2005-11-22', 'studyFirstSubmitQcDate': '2005-11-23', 'lastUpdatePostDateStruct': {'date': '2007-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RLS symptom severity, measured bi-weekly'}], 'secondaryOutcomes': [{'measure': 'Sleep efficiency, measured bi-weekly'}, {'measure': 'Insomnia severity, measured bi-weekly'}, {'measure': 'Day time sleepiness, measured bi-weekly'}]}, 'conditionsModule': {'keywords': ['Restless legs syndrome', 'Insomnia', 'Daytime sleepiness', 'Exercise'], 'conditions': ['Restless Legs Syndrome', 'Insomnia']}, 'descriptionModule': {'briefSummary': 'A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome (RLS). We, the researchers at Northeastern Ohio Universities College of Medicine, hypothesize that, relative to a control group, RLS sufferers who participate in an aerobic exercise intervention will demonstrate:\n\n1. reduced RLS symptoms;\n2. improved sleep quality;\n3. reduced daytime sleepiness.', 'detailedDescription': 'We will implement an exercise intervention among persons who suffer from RLS.\n\nStudy members will be Veterans, over the age of 40, who have been identified as RLS cases as part of our larger study of "The Prevalence and Outcomes of Restless Legs Syndrome among Veterans." We will use a cross-over design in which Veterans will be randomly assigned to the exercise intervention or control. Each arm of the study will be 3 months duration.\n\nThe protocol for the intervention will consist of twice weekly supervised exercise sessions. The goal for exercise participants will be to engage in continuous aerobic exercise for 45 minutes at an intensity of approximately 60% of VO2max. The control will be weekly support group meetings.\n\nOutcomes will be measured using standardized sleep scales, actigraphy, and daily sleep and exercise logs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets case definition for RLS with symptoms at least one day a week\n* Age 40 and older\n* Moderate or severe insomnia\n* Able to engage in moderate exercise\n* Permission of primary care physician to participate in exercise.\n\nExclusion Criteria:\n\n* Serum ferritin below 50 ng/ml\n* Body mass index (BMI) greater than 40\n* History of recent myocardial infarction or stroke\n* Alcohol use, more than 3 drinks a day\n* Current use of medications for sleep'}, 'identificationModule': {'nctId': 'NCT00258492', 'briefTitle': 'Restless Legs Syndrome Exercise Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Northeastern Ohio Universities College of Medicine'}, 'officialTitle': 'The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention', 'orgStudyIdInfo': {'id': 'DAMD17-03-1-0082'}, 'secondaryIdInfos': [{'id': 'DAMD17-03-1-0082'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Aerobic exercise', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Claire C. Bourguet, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northeastern Ohio Universities College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northeastern Ohio Universities College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Louis Stokes VA Medical Center', 'class': 'FED'}, {'name': 'The University of Akron', 'class': 'OTHER'}, {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}]}}}